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    Clinical Trial Results:
    A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects with Genotype 2 or 3 Chronic HCV Infection

    Summary
    EudraCT number
    		 2013-002641-11
    Trial protocol
    		 GB  
    Global end of trial date
    07 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2017
    First version publication date
    06 Jul 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-334-0153
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01962441
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were: - To determine the efficacy of sofosbuvir (SOF) + ribavirin (RBV) for 16 or 24 weeks as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of treatment (SVR12) - To determine the efficacy of SOF+RBV+pegylated interferon alfa 2a (Peg-IFN) for 12 weeks as measured by the proportion of participants with SVR12 - To evaluate the safety and tolerability of all 3 treatment arms as assessed by review of the accumulated safety data.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 254
    Country: Number of subjects enrolled
    Australia: 128
    Country: Number of subjects enrolled
    United States: 93
    Country: Number of subjects enrolled
    Canada: 84
    Country: Number of subjects enrolled
    New Zealand: 42
    Worldwide total number of subjects
    601
    EEA total number of subjects
    254
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    570
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe, North America, Australia, and New Zealand. The first participant was screened on 24 September 2013. The last study visit occurred on 07 July 2016.

    Pre-assignment
    Screening details
    		 776 participants were screened.

    Period 1
    Period 1 title
    Randomized Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF+RBV 16 Weeks
    Arm description
    		 Randomized Period: Sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV) for 16 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF, Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 SOF+RBV 24 Weeks
    Arm description
    		 Randomized Period: SOF+RBV 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF, Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 SOF+RBV+Peg-IFN 12 Weeks
    Arm description
    		 Randomized Period: SOF+RBV + pegylated interferon (Peg-IFN) for 12 weeks. Participants in this group were not eligible to enroll into the Retreatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF, Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    Peg-IFN
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 μg administered once weekly

    Number of subjects in period 1 [1]
    		SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Started
    196
    199
    197
    Completed
    190
    190
    189
    Not completed
    6
    9
    8
         Withdrew Consent
    3
    3
    2
         Adverse event, non-fatal
    1
    1
    -
         Death
    -
    -
    2
         Protocol Violation
    -
    1
    -
         Lost to follow-up
    2
    4
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 9 participants who were randomized but never treated are not included in the subject disposition table.
    Period 2
    Period 2 title
    Retreatment Substudy
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF+RBV 16 Weeks, Then Retreatment with SOF+Peg-IFN+RBV 12 Wks
    Arm description
    		 Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF, Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    Peg-IFN
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 μg administered once weekly

    Arm title
    		 SOF+RBV 24 Weeks, Then Retreatment with SOF+Peg-IFN+RBV 12 Wks
    Arm description
    		 Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF, Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg administered once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    Peg-IFN
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 μg administered once weekly

    Number of subjects in period 2 [2]
    		SOF+RBV 16 Weeks, Then Retreatment with SOF+Peg-IFN+RBV 12 Wks SOF+RBV 24 Weeks, Then Retreatment with SOF+Peg-IFN+RBV 12 Wks
    Started
    20
    10
    Completed
    18
    10
    Not completed
    2
    0
         Lost to follow-up
    1
    -
         Lack of efficacy
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 30 participants who experienced virologic failure enrolled into the Retreatment Substudy.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF+RBV 16 Weeks
    Reporting group description
    		 Randomized Period: Sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV) for 16 weeks

    Reporting group title
    SOF+RBV 24 Weeks
    Reporting group description
    		 Randomized Period: SOF+RBV 24 weeks

    Reporting group title
    SOF+RBV+Peg-IFN 12 Weeks
    Reporting group description
    		 Randomized Period: SOF+RBV + pegylated interferon (Peg-IFN) for 12 weeks. Participants in this group were not eligible to enroll into the Retreatment Period.

    Reporting group values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks Total
    Number of subjects
    		 196 199 197 592
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51 ( 9.7 ) 49 ( 9.8 ) 50 ( 10.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 62 70 65 197
        Male
    		 134 129 132 395
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 5 5 2 12
        Not Hispanic or Latino
    		 188 188 191 567
        Not Disclosed
    		 3 6 4 13
    Race
    Units: Subjects
        Black or African American
    		 2 2 2 6
        White
    		 162 168 165 495
        Asian
    		 29 26 25 80
        American Indian/ Alaska Native/ First Nations
    		 2 0 0 2
        Hawaiian or Pacific Islander
    		 0 1 2 3
        Other
    		 0 1 1 2
        Not Disclosed
    		 1 1 2 4
    HCV Genotype
    Units: Subjects
        Genotype 2
    		 15 17 16 48
        Genotype 3
    		 181 182 181 544
    IL28b Status
    CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 75 73 78 226
        CT
    		 94 95 98 287
        TT
    		 27 31 21 79
    HCV RNA Category
    Units: Subjects
        < 6 log10 IU/mL
    		 60 72 60 192
        ≥ 6 log10 IU/mL
    		 136 127 137 400
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.3 ( 0.68 ) 6.2 ( 0.71 ) 6.3 ( 0.69 ) -

    End points

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    End points reporting groups
    Reporting group title
    SOF+RBV 16 Weeks
    Reporting group description
    		 Randomized Period: Sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV) for 16 weeks

    Reporting group title
    SOF+RBV 24 Weeks
    Reporting group description
    		 Randomized Period: SOF+RBV 24 weeks

    Reporting group title
    SOF+RBV+Peg-IFN 12 Weeks
    Reporting group description
    		 Randomized Period: SOF+RBV + pegylated interferon (Peg-IFN) for 12 weeks. Participants in this group were not eligible to enroll into the Retreatment Period.
    Reporting group title
    SOF+RBV 16 Weeks, Then Retreatment with SOF+Peg-IFN+RBV 12 Wks
    Reporting group description
    		 Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.

    Reporting group title
    SOF+RBV 24 Weeks, Then Retreatment with SOF+Peg-IFN+RBV 12 Wks
    Reporting group description
    		 Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.

    Subject analysis set title
    SOF+RBV 16 Weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    SOF+RBV for 16 weeks

    Subject analysis set title
    SOF+RBV 24 Weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    SOF+RBV for 24 weeks

    Subject analysis set title
    SOF+RBV+Peg-IFN 12 Weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    SOF+RBV+Peg-IFN for 12 weeks

    Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Posttreatment Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    196
    199
    197
    Units: percentage of participants
        number (not applicable)
    71.9
    85.4
    92.9
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [2]
    End point description
    Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    196
    199
    197
    Units: percentage of participants
        number (not applicable)
    1.5
    1.5
    1.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

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    End point title
    		 Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    196
    199
    197
    Units: percentage of participants
    number (not applicable)
        SVR4
    73
    85.9
    95.9
        SVR24
    71.9
    84.4
    93.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
    End point description
    Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. 9999 = NA; Treatment for these groups was only 12 or 16 weeks.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8, 12, 16, 20, and 24
    End point values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    196
    199
    197
    Units: percentage of participants
    number (not applicable)
        Wk 1 (16 Wk: n=196; 24 Wk: n=199; 12 Wk: n=197)
    14.8
    20.1
    25.9
        Wk 2 (16 Wk: n=195; 24 Wk: n=198; 12 Wk: n=197)
    53.3
    53.5
    67
        Wk 4 (16 Wk: n=194; 24 Wk: n=198; 12 Wk: n=195)
    86.6
    91.9
    97.4
        Wk 8 (16 Wk: n=193; 24 Wk: n=198; 12 Wk: n=195)
    99.5
    99.5
    99.5
        Wk 12 (16 Wk: n=190; 24 Wk: n=197; 12 Wk: n=194)
    100
    98.5
    100
        Wk 16 (16 Wk: n=191; 24 Wk: n=194)
    99
    99.5
    9999
        Wk 20 (24 Wk: n=194)
    9999
    99.5
    9999
        Wk 24 (24 Wk: n=193)
    9999
    100
    9999
    No statistical analyses for this end point

    Secondary: HCV RNA at Weeks 1, 2, 4, 8, and 12

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    End point title
    		 HCV RNA at Weeks 1, 2, 4, 8, and 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8, and 12
    End point values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    196
    199
    197
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Wk 1 (16 Wk: n=194; 24 Wk: n=197; 12 Wk: n=194)
    2.13 ( 0.658 )
    2.08 ( 0.749 )
    1.81 ( 0.576 )
        Wk 2 (16 Wk: n=191; 24 Wk: n=196; 12 Wk: n=195)
    1.44 ( 0.436 )
    1.45 ( 0.487 )
    1.32 ( 0.342 )
        Wk 4 (16 Wk: n=193; 24 Wk: n=198; 12 Wk: n=195)
    1.19 ( 0.156 )
    1.21 ( 0.287 )
    1.16 ( 0 )
        Wk 8 (16 Wk: n=193; 24 Wk: n=198; 12 Wk: n=194)
    1.15 ( 0.021 )
    1.15 ( 0.1 )
    1.15 ( 0 )
        Wk 12 (16 Wk: n=191; 24 Wk: n=197; 12 Wk: n=194)
    1.15 ( 0 )
    1.17 ( 0.318 )
    1.15 ( 0 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

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    End point title
    		 Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 1, 2, 4, 8, and 12
    End point values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    196
    199
    197
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Wk 1 (16 Wk: n=194; 24 Wk: n=197; 12 Wk: n=194)
    -4.18 ( 0.559 )
    -4.15 ( 0.664 )
    -4.46 ( 0.556 )
        Wk 2 (16 Wk: n=191; 24 Wk: n=196; 12 Wk: n=195)
    -4.86 ( 0.661 )
    -4.78 ( 0.714 )
    -4.96 ( 0.661 )
        Wk 4 (16 Wk: n=193; 24 Wk: n=198; 12 Wk: n=195)
    -5.11 ( 0.671 )
    -5.02 ( 0.735 )
    -5.12 ( 0.699 )
        Wk 8 (16 Wk: n=193; 24 Wk: n=198; 12 Wk: n=194)
    -5.16 ( 0.684 )
    -5.08 ( 0.708 )
    -5.12 ( 0.691 )
        Wk 12 (16 Wk: n=191; 24 Wk: n=197; 12 Wk: n=194)
    -5.15 ( 0.686 )
    -5.05 ( 0.788 )
    -5.12 ( 0.691 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing On-Treatment Virologic Failure

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    End point title
    		 Percentage of Participants Experiencing On-Treatment Virologic Failure
    End point description
    On-treatment virologic failure was defined as: • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks
    End point values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    196
    199
    197
    Units: percentage of participants
        number (not applicable)
    0
    1.5
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Viral Relapse

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    End point title
    		 Percentage of Participants Experiencing Viral Relapse
    End point description
    Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    195
    195
    195
    Units: percentage of participants
        number (not applicable)
    26.7
    12.3
    4.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 weeks plus 30 days (Randomized Period); Up to 12 additional weeks plus 30 days (Retreatment Period)
    Adverse event reporting additional description
    Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0, 19.0
    Reporting groups
    Reporting group title
    Randomized Period: SOF+RBV 16 Weeks
    Reporting group description
    		 Randomized Period: SOF+RBV for 16 weeks

    Reporting group title
    Randomized Period: SOF+RBV 24 Weeks
    Reporting group description
    		 Randomized Period: SOF+RBV 24 weeks

    Reporting group title
    Randomized Period: SOF+RBV+Peg-IFN 12 Weeks
    Reporting group description
    		 Randomized Period: SOF+RBV+Peg-IFN for 12 weeks.

    Reporting group title
    Retreatment Period: SOF+RBV+Peg- IFN 12 Weeks
    Reporting group description
    		 Retreatment Period: Participants from the SOF+RBV 16 Weeks or 24 Weeks groups who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+RBV+Peg-IFN for 12 weeks.

    Serious adverse events
    		 Randomized Period: SOF+RBV 16 Weeks Randomized Period: SOF+RBV 24 Weeks Randomized Period: SOF+RBV+Peg-IFN 12 Weeks Retreatment Period: SOF+RBV+Peg- IFN 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 196 (4.08%)
    10 / 199 (5.03%)
    12 / 197 (6.09%)
    1 / 30 (3.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 199 (0.00%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 199 (0.00%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 199 (0.00%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Miscarriage of partner
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleuritic pain
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 199 (0.00%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Snake bite
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 199 (0.00%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 196 (0.51%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 199 (0.00%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    0 / 197 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 199 (0.00%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    1 / 197 (0.51%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 199 (0.50%)
    0 / 197 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Randomized Period: SOF+RBV 16 Weeks Randomized Period: SOF+RBV 24 Weeks Randomized Period: SOF+RBV+Peg-IFN 12 Weeks Retreatment Period: SOF+RBV+Peg- IFN 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    173 / 196 (88.27%)
    176 / 199 (88.44%)
    192 / 197 (97.46%)
    29 / 30 (96.67%)
    Investigations
    Platelet count decreased
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    3 / 197 (1.52%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    3
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    11 / 196 (5.61%)
    16 / 199 (8.04%)
    13 / 197 (6.60%)
    2 / 30 (6.67%)
         occurrences all number
    11
    17
    14
    3
    Dizziness postural
         subjects affected / exposed
    3 / 196 (1.53%)
    1 / 199 (0.50%)
    10 / 197 (5.08%)
    0 / 30 (0.00%)
         occurrences all number
    3
    1
    10
    0
    Dysgeusia
         subjects affected / exposed
    6 / 196 (3.06%)
    4 / 199 (2.01%)
    10 / 197 (5.08%)
    1 / 30 (3.33%)
         occurrences all number
    6
    4
    11
    1
    Headache
         subjects affected / exposed
    61 / 196 (31.12%)
    72 / 199 (36.18%)
    70 / 197 (35.53%)
    12 / 30 (40.00%)
         occurrences all number
    65
    86
    78
    13
    Lethargy
         subjects affected / exposed
    9 / 196 (4.59%)
    8 / 199 (4.02%)
    10 / 197 (5.08%)
    1 / 30 (3.33%)
         occurrences all number
    9
    8
    10
    1
    Memory impairment
         subjects affected / exposed
    10 / 196 (5.10%)
    3 / 199 (1.51%)
    5 / 197 (2.54%)
    1 / 30 (3.33%)
         occurrences all number
    10
    3
    5
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 196 (2.04%)
    7 / 199 (3.52%)
    12 / 197 (6.09%)
    0 / 30 (0.00%)
         occurrences all number
    4
    9
    12
    0
    Neutropenia
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    11 / 197 (5.58%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    12
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 196 (1.02%)
    3 / 199 (1.51%)
    10 / 197 (5.08%)
    0 / 30 (0.00%)
         occurrences all number
    2
    3
    10
    0
    Chills
         subjects affected / exposed
    3 / 196 (1.53%)
    4 / 199 (2.01%)
    21 / 197 (10.66%)
    1 / 30 (3.33%)
         occurrences all number
    3
    4
    21
    1
    Fatigue
         subjects affected / exposed
    74 / 196 (37.76%)
    83 / 199 (41.71%)
    92 / 197 (46.70%)
    18 / 30 (60.00%)
         occurrences all number
    78
    86
    92
    18
    Influenza like illness
         subjects affected / exposed
    7 / 196 (3.57%)
    8 / 199 (4.02%)
    39 / 197 (19.80%)
    6 / 30 (20.00%)
         occurrences all number
    7
    10
    42
    6
    Injection site rash
         subjects affected / exposed
    0 / 196 (0.00%)
    0 / 199 (0.00%)
    5 / 197 (2.54%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    5
    2
    Pyrexia
         subjects affected / exposed
    5 / 196 (2.55%)
    7 / 199 (3.52%)
    29 / 197 (14.72%)
    6 / 30 (20.00%)
         occurrences all number
    5
    8
    32
    8
    Eye disorders
    Dry eye
         subjects affected / exposed
    3 / 196 (1.53%)
    5 / 199 (2.51%)
    5 / 197 (2.54%)
    2 / 30 (6.67%)
         occurrences all number
    3
    5
    5
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    8 / 196 (4.08%)
    8 / 199 (4.02%)
    11 / 197 (5.58%)
    1 / 30 (3.33%)
         occurrences all number
    9
    8
    11
    1
    Abdominal pain upper
         subjects affected / exposed
    7 / 196 (3.57%)
    10 / 199 (5.03%)
    9 / 197 (4.57%)
    0 / 30 (0.00%)
         occurrences all number
    8
    11
    10
    0
    Diarrhoea
         subjects affected / exposed
    21 / 196 (10.71%)
    18 / 199 (9.05%)
    27 / 197 (13.71%)
    3 / 30 (10.00%)
         occurrences all number
    22
    20
    32
    4
    Dry mouth
         subjects affected / exposed
    3 / 196 (1.53%)
    7 / 199 (3.52%)
    12 / 197 (6.09%)
    0 / 30 (0.00%)
         occurrences all number
    3
    7
    12
    0
    Dyspepsia
         subjects affected / exposed
    10 / 196 (5.10%)
    12 / 199 (6.03%)
    11 / 197 (5.58%)
    1 / 30 (3.33%)
         occurrences all number
    12
    12
    11
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 196 (2.04%)
    8 / 199 (4.02%)
    3 / 197 (1.52%)
    2 / 30 (6.67%)
         occurrences all number
    4
    8
    3
    3
    Mouth ulceration
         subjects affected / exposed
    5 / 196 (2.55%)
    3 / 199 (1.51%)
    5 / 197 (2.54%)
    2 / 30 (6.67%)
         occurrences all number
    5
    4
    5
    2
    Nausea
         subjects affected / exposed
    32 / 196 (16.33%)
    34 / 199 (17.09%)
    50 / 197 (25.38%)
    7 / 30 (23.33%)
         occurrences all number
    33
    38
    51
    7
    Vomiting
         subjects affected / exposed
    10 / 196 (5.10%)
    21 / 199 (10.55%)
    19 / 197 (9.64%)
    0 / 30 (0.00%)
         occurrences all number
    10
    23
    28
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 196 (5.10%)
    19 / 199 (9.55%)
    28 / 197 (14.21%)
    2 / 30 (6.67%)
         occurrences all number
    10
    19
    28
    2
    Dyspnoea
         subjects affected / exposed
    3 / 196 (1.53%)
    3 / 199 (1.51%)
    5 / 197 (2.54%)
    2 / 30 (6.67%)
         occurrences all number
    3
    3
    5
    2
    Dyspnoea exertional
         subjects affected / exposed
    22 / 196 (11.22%)
    22 / 199 (11.06%)
    30 / 197 (15.23%)
    1 / 30 (3.33%)
         occurrences all number
    22
    22
    30
    1
    Epistaxis
         subjects affected / exposed
    7 / 196 (3.57%)
    2 / 199 (1.01%)
    12 / 197 (6.09%)
    0 / 30 (0.00%)
         occurrences all number
    7
    2
    12
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    6 / 196 (3.06%)
    9 / 199 (4.52%)
    16 / 197 (8.12%)
    0 / 30 (0.00%)
         occurrences all number
    6
    9
    16
    0
    Dry skin
         subjects affected / exposed
    15 / 196 (7.65%)
    22 / 199 (11.06%)
    25 / 197 (12.69%)
    3 / 30 (10.00%)
         occurrences all number
    15
    22
    25
    3
    Pruritus
         subjects affected / exposed
    21 / 196 (10.71%)
    24 / 199 (12.06%)
    22 / 197 (11.17%)
    6 / 30 (20.00%)
         occurrences all number
    22
    26
    22
    7
    Pruritus generalised
         subjects affected / exposed
    9 / 196 (4.59%)
    16 / 199 (8.04%)
    15 / 197 (7.61%)
    0 / 30 (0.00%)
         occurrences all number
    9
    17
    16
    0
    Rash
         subjects affected / exposed
    24 / 196 (12.24%)
    27 / 199 (13.57%)
    39 / 197 (19.80%)
    6 / 30 (20.00%)
         occurrences all number
    25
    30
    39
    6
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    12 / 196 (6.12%)
    16 / 199 (8.04%)
    17 / 197 (8.63%)
    1 / 30 (3.33%)
         occurrences all number
    12
    17
    17
    1
    Depressed mood
         subjects affected / exposed
    8 / 196 (4.08%)
    11 / 199 (5.53%)
    17 / 197 (8.63%)
    0 / 30 (0.00%)
         occurrences all number
    8
    11
    17
    0
    Depression
         subjects affected / exposed
    1 / 196 (0.51%)
    8 / 199 (4.02%)
    10 / 197 (5.08%)
    3 / 30 (10.00%)
         occurrences all number
    1
    8
    10
    3
    Insomnia
         subjects affected / exposed
    47 / 196 (23.98%)
    56 / 199 (28.14%)
    50 / 197 (25.38%)
    2 / 30 (6.67%)
         occurrences all number
    48
    59
    51
    2
    Irritability
         subjects affected / exposed
    17 / 196 (8.67%)
    25 / 199 (12.56%)
    21 / 197 (10.66%)
    3 / 30 (10.00%)
         occurrences all number
    17
    25
    21
    3
    Mood swings
         subjects affected / exposed
    3 / 196 (1.53%)
    7 / 199 (3.52%)
    5 / 197 (2.54%)
    3 / 30 (10.00%)
         occurrences all number
    3
    7
    5
    3
    Sleep disorder
         subjects affected / exposed
    15 / 196 (7.65%)
    7 / 199 (3.52%)
    11 / 197 (5.58%)
    2 / 30 (6.67%)
         occurrences all number
    15
    7
    11
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 196 (5.10%)
    15 / 199 (7.54%)
    25 / 197 (12.69%)
    3 / 30 (10.00%)
         occurrences all number
    10
    17
    25
    3
    Back pain
         subjects affected / exposed
    10 / 196 (5.10%)
    14 / 199 (7.04%)
    15 / 197 (7.61%)
    2 / 30 (6.67%)
         occurrences all number
    11
    14
    15
    2
    Musculoskeletal pain
         subjects affected / exposed
    9 / 196 (4.59%)
    22 / 199 (11.06%)
    11 / 197 (5.58%)
    1 / 30 (3.33%)
         occurrences all number
    9
    27
    12
    1
    Myalgia
         subjects affected / exposed
    12 / 196 (6.12%)
    19 / 199 (9.55%)
    33 / 197 (16.75%)
    7 / 30 (23.33%)
         occurrences all number
    12
    19
    34
    7
    Neck pain
         subjects affected / exposed
    2 / 196 (1.02%)
    2 / 199 (1.01%)
    1 / 197 (0.51%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    1
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 196 (6.12%)
    14 / 199 (7.04%)
    7 / 197 (3.55%)
    1 / 30 (3.33%)
         occurrences all number
    12
    16
    7
    1
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 196 (4.08%)
    10 / 199 (5.03%)
    3 / 197 (1.52%)
    0 / 30 (0.00%)
         occurrences all number
    8
    10
    3
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    13 / 196 (6.63%)
    16 / 199 (8.04%)
    35 / 197 (17.77%)
    3 / 30 (10.00%)
         occurrences all number
    13
    16
    35
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2013
    ● Corrections were made to the testing included in the optional viral dynamic substudy, as well as to the sample collection at baseline, on-treatment, and early termination visits.
    24 Oct 2013
    ● The list of clinical laboratory analytes was updated to include additional tests and the stopping requirements for SOF were clarified, based on Food and Drug Administration (FDA) recommendations. ● Typographical errors in the study design and inclusion criteria were corrected, and the specimen storage guidelines and disallowed concomitant medication list were updated. In addition, the power size calculations were modified as required to demonstrate superiority across study arms.
    01 Apr 2015
    ● The results of the primary efficacy endpoint interim analysis (for SVR12) indicated that treatment with SOF+Peg-IFN+RBV for 12 weeks resulted in a higher SVR12 rate compared with SOF+RBV, both for subjects treated for 16 weeks and for subjects treated for 24 weeks. Based on these data and considering that all subjects were required to be considered IFN eligible in the initial study protocol, a retreatment substudy was incorporated in the study design. In the substudy, treatment with SOF+Peg-IFN+RBV was offered to subjects who were randomized to receive SOF+RBV for 16 or 24 weeks and experienced virologic failure during treatment or relapsed at or before posttreatment Week 24.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26248087
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